What is the enablement requirement for biotechnology patents with respect to biological deposits?
The enablement requirement for biotechnology patents with respect to biological deposits is based on 35 U.S.C. 112(a). According to MPEP 2411.01:
“Rejection for lack of an enabling disclosure without access to a specific biological material. This ground of rejection should be accompanied by evidence of scientific reasoning to support the conclusion that a person skilled in the art could not make or use the invention defined in and commensurate with the claims without access to the specific biological material.”
This means that if a biological material is necessary for the invention and is not readily available, the applicant must provide a deposit of the material to enable others to make and use the invention. Without such a deposit, the examiner may reject the application for lack of enablement.
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